concomitant administration of a new hexavalent vaccine with a meningococcal serogroup c conjugate vaccine in healthy infants during primary series immunisation followed by booster vaccination

Conditions: Neisseria Meningitidis; Bacterial Infections; Virus Diseases

Summary: primary series primary objectives * to demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup c conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a menc vaccine concomitantly in term of seroprotection rate for hepatitis b one month after the third dose of the hexavalent vaccine * to demonstrate that the concomitant administration of a menc vaccine with the hexavalent vaccine induces an acceptable response for menc in term of seroprotection rate (spr) one month after the second dose of menc booster primary objectives - to describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group acwy conjugate (menacwy) vaccine either co-administered at 12 months of age or given separately.

primary series secondary objectives * to describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to menc * to describe the antibody response to menc vaccine when a menc vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of menc vaccine * to describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a menc vaccine booster secondary objectives * to describe the antibody (ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose) * to describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group acwy conjugate (menacwy) vaccine either co-administered at 12 months of age or given separately.

Eligibility criteria:
inclusion criteria: * healthy infant 46 to 74 days of age (both inclusive) * born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg * subject's parent(s) or legal representative able to comply with the study procedures exclusion criteria: * participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure * receipt of any vaccine in the 4 weeks preceding each study vaccination * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection * know or suspected congenital, hereditary or acquired immunodeficiency * history of seizures or encephalopathy * known thrombocytopenia * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection * chronic illness that could interfere with trial conduct or completion * known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines * contraindication to any of the study vaccines * known personal or maternal history of hepatitis b or hepatitis c seropositivity * history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, haemophilus influenzae type b or meningococcal serogroup c infection * receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth * identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.